Behavioral Therapy Of Obstetric Sphincter Tears

Fecal Incontinence Clinical Trial

— BOOST  

Official title:

BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166399
• Other study ID #: 20P01
• Status: Completed
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2020
• Source: NICHD Pelvic Floor Disorders Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.

Description:

The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.

Secondary aims of the cohort study are:

1. To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI

2. To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms

3. To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms

4. To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: October 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Assessed by 2 weeks postpartum

1. Vaginal delivery >= 28 weeks singleton gestation

2. Documented repair to the anal sphincter at delivery

3. First vaginal delivery

4. Ambulatory

5. Able to give informed consent 6 Adult women >= 18 years of age

Inclusion Criteria at 2 weeks postpartum

1. Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)

2. Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)

3. Pre-pregnancy FI (defined as the leakage of liquid/solid stool and mucus >= once per month for at least 12 weeks prior to this pregnancy)

4. Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)

5. Presence of rectovaginal fistula

6. Any participation in other pharmacologic or behavioral studies for FI

7. Previous pregnancy >=28 weeks delivered vaginally or by Cesarean section

Related Conditions & MeSH terms

• Fecal Incontinence

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of California San Diego	La Jolla	California
United States	Loyola University	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
NICHD Pelvic Floor Disorders Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of FI	The primary aim for this study is to determine the incidence of FI symptoms (based on the FISI)at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.	6 and 12 months postpartum
Secondary	Incidence of FI	A secondary aim for this study is to determine the incidence of FI symptoms (based on the FISI) at 24 weeks postpartum in primiparous women sustaining an OASI.	24 weeks postpartum
Secondary	Fecal urgency	Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire	24 weeks postpartum

External Links

•   Network website